Umeclidinium and vilanterol (Inhalation route)

Pronunciation:

ue-mek-li-DIN-ee-um BROE-mide, vye-LAN-ter-ol trye-FEN-a-tate

Brand Names:

Anoro Ellipta

Dosage Forms:

Powder

Warnings:

Inhalation route(Powder)

Asthma-related death: Long-acting beta(2)-adrenergic agonists (LABA) increase the risk of asthma-related death. Data from a large placebo-controlled US trial that compared the safety of another LABA (salmeterol) with placebo added to the usual asthma therapy showed an increase in asthma-related deaths in subjects receiving salmeterol. This finding with salmeterol is considered a class effect of all LABA, including vilanterol, one of the active ingredients in the umeclidinium/vilanterol combination. The safety and efficacy of umeclidinium/vilanterol in patients with asthma have not been established. Umeclidinium/vilanterol is not indicated for the treatment of asthma .

Classifications:

Therapeutic

Respiratory Agent

Pharmacologic

Umeclidinium

Uses of This Medicine:

Umeclidinium and vilanterol combination is used to treat air flow blockage in chronic obstructive pulmonary disease (COPD). This includes chronic bronchitis and emphysema.

Umeclidinium and vilanterol combination should not be used for acute breathing problems or in patients with asthma.

Inhaled umeclidinium is an anticholinergic. Inhaled vilanterol is a long-acting bronchodilator. Bronchodilators are medicines that are breathed in through the mouth to open up the bronchial tubes (air passages) in the lungs.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children

Use of umeclidinium and vilanterol combination is not recommended in children. Safety and efficacy have not been established.

Older adults

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of umeclidinium and vilanterol combination in the elderly.

Pregnancy

Pregnancy Category

Explanation

All Trimesters

C

Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Amifampridine

Amisulpride

Bepridil

Cisapride

Dronedarone

Fluconazole

Ketoconazole

Mesoridazine

Nelfinavir

Pimozide

Piperaquine

Posaconazole

Saquinavir

Sparfloxacin

Terfenadine

Thioridazine

Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Amineptine

Amiodarone

Amitriptyline

Amitriptylinoxide

Amoxapine

Anagrelide

Aripiprazole

Atazanavir

Boceprevir

Bupropion

Buserelin

Butriptyline

Ceritinib

Clarithromycin

Clomipramine

Cobicistat

Conivaptan

Crizotinib

Dabrafenib

Degarelix

Delamanid

Desipramine

Deslorelin

Dibenzepin

Donepezil

Dothiepin

Doxepin

Escitalopram

Gonadorelin

Goserelin

Histrelin

Hydroxychloroquine

Idelalisib

Imipramine

Indinavir

Iprindole

Itraconazole

Ivabradine

Leuprolide

Levofloxacin

Lofepramine

Lopinavir

Melitracen

Metronidazole

Nafarelin

Nefazodone

Nilotinib

Nortriptyline

Opipramol

Oxymorphone

Panobinostat

Pasireotide

Pimavanserin

Pitolisant

Propizepine

Protriptyline

Quetiapine

Ritonavir

Sulpiride

Tacrolimus

Telaprevir

Telithromycin

Tianeptine

Tiotropium

Tipranavir

Trimipramine

Triptorelin

Troleandomycin

Vemurafenib

Vinflunine

Voriconazole

Zuclopenthixol

Other interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Grapefruit Juice

Other medical problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Allergy to milk proteins Should not be used in patients with these conditions.

Bladder blockage or

Diabetes or

Enlarged prostate (BPH, prostatic hyperplasia) or

Heart or blood vessel disease or

Heart rhythm problems (eg, arrhythmia, prolonged QT interval) or

Hypertension (high blood pressure) or

Hyperthyroidism (overactive thyroid) or

Hypokalemia (low potassium in the blood) or

Ketoacidosis (high ketones in the blood) or

Narrow-angle glaucoma or

Problems passing urine or

Seizures Use with caution. May make these conditions worse.

Proper Use of This Medicine:

Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop using this medicine without telling your doctor. To do so may increase the chance of side effects.

Inhaled umeclidinium and vilanterol combination comes with patient directions or a Medication Guide. Read the directions carefully before using this medicine. If you do not understand the directions or you are not sure how to use the inhaler, ask your doctor to show you what to do. Also, ask your doctor to check regularly how you use the inhaler to make sure you are using it properly.

Use this medicine at the same time each day.

Do not stop using this medicine or other breathing medicines that your doctor has prescribed for you unless you have discussed this with your doctor.

To use the inhaler:

This medicine comes in a foil tray. Peel back the lid to open the tray.

Slide the inhaler cover down until you hear a clicking sound. The inhaler is now ready to use. Do not open the cover of the inhaler until you are ready to use it. If you open and close the inhaler without inhaling the dose, you will lose the medicine.

Turn your head away from the inhaler, and breathe out fully. Do not breathe into the inhaler.

Put the mouthpiece between your lips, and close your lips around the mouthpiece. Do not block the air vent with your fingers.

Breathe in through your mouth as deeply as you can until you have taken a full deep breath. Do not breathe through your nose.

Hold your breath and remove the mouthpiece from your mouth. Continue holding your breath as long as you can up to 3 or 4 seconds before breathing out slowly. This gives the medicine time to settle in your airways and lungs.

When you are finished, you may clean the mouthpiece with a dry tissue, if needed, before closing the inhaler cover.

The inhaler has a window that shows the number of doses that are left. This tells you when you are getting low on medicine. When the inhaler has less than 10 doses left, the left half of the counter will show up in red to remind you to refill your prescription.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For inhalation dosage form (powder):

For maintenance treatment of COPD:

Adults One inhalation once a day. Do not take more than one inhalation every 24 hours.

Children Use is not recommended.

Missed dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Keep this medicine in a dry place away from heat and sunlight. Throw away this medicine 6 weeks after opening or when the counter reads "0".

Precautions While Using This Medicine:

If you will be using this medicine for a long time, it is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects.

Tell your doctor if you are also using other medicines for your COPD.

This medicine should not be used if you are having a severe COPD attack, or if symptoms of a COPD attack has already started. Your doctor may prescribe another medicine for you to use in case of an acute COPD attack. If the other medicine does not work as well, tell your doctor right away.

Talk with your doctor or get medical care right away if:

Your symptoms do not improve after using this medicine for 1 week or if they become worse.

Your short-acting inhaler does not seem to work as well as it used to and you need it more often than normal (eg, you use 1 whole canister of the short-acting inhaler in 8 weeks time, or you need to use 4 or more inhalations of the short-acting inhaler for 2 or more days in a row).

You have a big decrease in your peak flow when measured as directed by your doctor.

This medicine should not be used together with similar inhaled medicines such as arformoterol (Brovana®), budesonide/formoterol (Symbicort®), formoterol (Foradil®, Perforomist®), indacaterol (Onbrez®), or salmeterol (Serevent®).

This medicine may cause paradoxical bronchospasm, which means your breathing or wheezing will get worse. Paradoxical bronchospasm may be life-threatening. Check with your doctor right away if you have coughing, difficulty breathing, shortness of breath, or wheezing after using this medicine.

If you develop a skin rash, hives, or any allergic reaction to this medicine, stop using the medicine and check with your doctor as soon as possible.

Check with your doctor right away if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

This medicine may affect blood sugar and potassium levels. If you have heart disease or are diabetic and notice a change in the results of your blood or urine sugar or potassium tests, check with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Body aches or pain

chest pain

congestion

cough

dryness or soreness of the throat

fever

headache

hoarseness

pain or tenderness around the eyes and cheekbones

stuffy or runny nose

tender, swollen glands in the neck

tightness of the chest

trouble breathing

trouble swallowing

voice changes

Rare

Chest discomfort

dizziness

fainting

fast or irregular heartbeat

nausea

pain or discomfort in the arms, jaw, back, or neck

sweating

vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Diarrhea

difficulty having a bowel movement (stool)

muscle spasms

Rare

Acid or sour stomach

belching

burning, dry, or itching eyes

discharge or excessive tearing

dry mouth

heartburn

indigestion

lack or loss of strength

rash or itching skin

redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid

stomach discomfort, upset, or pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.